MAUDE Adverse Event Report: CARTIVA, INC CARTIVA SYNTHETIC CARTILAGE IMPLANT; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Catalog Number UNK_WCA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient had the device implanted in the left great toe due to arthritis.The patient stated that the implant has failed and the patient has very limited mobility in the toe joint nor does the toe joint flex as it should.Approximately 16 months post-opt the patient fractured the first metatarsal in the same foot while walking as a result of the immobility of the toe.7 months later the patient visited the surgeon because of continuing pain and immobility.Patient reports having pain during walking, and increased pain afterwards, not only in the toe but also at the fracture site.

• Brand Name: CARTIVA SYNTHETIC CARTILAGE IMPLANT
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• MDR Report Key: 12706274
• MDR Text Key: 281844096
• Report Number: 3009351194-2021-00119
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WCA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 66